CRA II - Sponsor Dedicated (Home-Based - FL / GA)

Overview CRA II - Sponsor Dedicated (Home-Based - FL / GA) Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know. Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life. We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment to evaluate site performance and provide recommendations; communicates/escalates serious issues to the project team and develops action plans. Maintains knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. Verifies informed consent has been adequately performed and documented for each subject/patient. Protects confidentiality and assesses factors affecting subject safety and data integrity at investigator/physician sites (e.g., protocol deviation/violations and pharmacovigilance issues). Per the CMP/SMP: Assesses site processes. Conducts Source Document Review of site documents and medical records. Verifies CRF data is accurate and complete. Applies query resolution techniques remotely and on site, guiding site staff to resolve queries within timelines. Supports data capture and data review using available hardware/software. Verifies site compliance with electronic data capture requirements. May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies IP dispensing and administration per protocol. Manages IP labeling, import, release/return in line with GCP/local regulations and procedures. Routinely reviews the Investigator Site File (ISF) for accuracy and completeness. Reconciles ISF with the Trial Master File (TMF). Ensures archiving of essential documents per local guidelines and regulations. Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other project documents. Supports subject/patient recruitment and retention. Enters data into tracking systems to monitor observations, status and action items. For assigned activities, understands project scope, budgets, and timelines; manages site-level activities/communication to meet objectives and timelines. Adapts to changing priorities to achieve goals. Acts as primary liaison with study site personnel or with Central Monitoring Associate. Ensures all sites and project team members are trained and compliant with applicable requirements. Prepares for and attends Investigator Meetings and sponsor meetings. Participates in global clinical monitoring/project staff meetings and attends clinical training sessions as required by project. Provides guidance towards audit readiness and supports preparation for audits and follow-up actions. Maintains knowledge of ICH/GCP Guidelines or other applicable guidance, regulations, and company SOPs/processes; completes assigned training. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include: site support throughout study lifecycle, knowledge of local requirements for real world late phase study designs, chart abstraction activities and data collection. Collaboration with Sponsor affiliates, medical science liaisons and local country staff. May train junior staff. Identify and communicate out-of-scope activities to Lead CRA/Project Manager. Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and HCP associations. Qualifications Bachelor's degree or RN in a related field or equivalent combination of education, training and experience Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills and be able to embrace new technologies Excellent communication, presentation and interpersonal skills Ability to manage required travel of up to 75% on a regular basis US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. You must comply with site requests as a condition of employment. Non-compliance may result in a site barring entry, which could affect employment. Benefits and Salary At Syneos Health, we provide an environment where our people can thrive, develop and advance. Benefits may include a company car or car allowance, health benefits (medical, dental, vision), 401k with company match, eligibility for an Employee Stock Purchase Plan, potential for commissions/bonus, and flexible PTO and sick time. Paid sick time varies by state and municipality; Syneos complies with applicable laws. Salary Range: $70,100.00 - $126,100.00 The base salary range represents the anticipated low and high of the company range for this position. Actual salary will vary based on qualifications, skills, and proficiency. Additional Information Tasks, duties, and responsibilities listed are not exhaustive. The Company may assign additional tasks at its discretion. Equal/alternative qualifications may be considered. This description does not create a contract. The Company complies with applicable laws and is committed to equal opportunity employment. Website: #J-18808-Ljbffr